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Preventing fungal contamination in pharmaceuticals

European Pharmaceutical Review

In a review on fungal-contaminated compounded pharmaceuticals and medical devices, researchers have described how the contamination of these products can be due to breaches in sterile compounding procedures. One case of drug contamination from 2021 was highlighted in the paper. Ahmed et al. According to Ahmed et al.,

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Transforming pharmaceutical manufacturing: The AI revolution

European Pharmaceutical Review

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. AI and future perspectives: a glimpse into tomorrow Figure 2: adapted from Saha, G.

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Pharmaceutical microbiology: key developments 2022

European Pharmaceutical Review

This Q&A covers the key developments in pharmaceutical microbiology in 2022, featuring insight from pharmaceutical microbiology experts: Dr Tim Sandle, Head of Microbiology, Bio Products Laboratory Limited. What were the main challenges for pharmaceutical microbiology in 2022?

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Drug safety driving pyrogen testing market expansion

European Pharmaceutical Review

Drivers of the pyrogen testing market Increased R&D activities within the pharmaceutical and biopharmaceutical sector and a focus on biologics, were reported to hold significant growth opportunities for the pyrogen testing market. The market is predicted to grow at a CAGR of 8.2 percent from 2023 to 2032, according to the research.

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Strengthening and transforming the pharmaceutical supply chain

European Pharmaceutical Review

Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation. What are the top three supply-related challenges facing pharmaceutical manufacturers?

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What gene therapy manufacturers can gain from collaboration

European Pharmaceutical Review

Challenges in gene therapy manufacturing Photo: courtesy of PTC Therapeutics The biotech industry is facing a bottleneck in product manufacturing, with more than 1,000 gene therapies currently being developed as potential clinical candidates, 1 and not nearly enough capacity in manufacturing facilities to accommodate them.

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EMA publishes updated Q&A for ICH M10

European Pharmaceutical Review

The ICH M10 guideline provides recommendations on the validation of bioanalytical assays for chemical and biological drugs and their metabolites in biological matrices. These concentration measurements are used as part of regulatory decisions regarding the safety and efficacy of medicinal products.